Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease

Phase 2

• Conditions: Acute-graft-versus-host Disease
• Interventions: Drug: Cannabidiol; Drug: Methylprednisolone; Drug: Calcineurin inhibitor

• Registration Number: NCT02392780
• Lead Sponsor: moshe yeshurun

Brief Summary

Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase 2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD compared to control patients with a hazard ratio of 0.3. Based on these results the investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-18
• Last Update Submitted: 2015-03-18
• Study First Posted: 2015-03-19
• Last Update Posted: 2015-03-19
• Study Start: 2015-04
• Primary Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients 18 years or older
2. After allogeneic transplantation
3. Grade III or IV acute GVHD
4. No psychiatric contra-indication
5. Informed consent

Exclusion Criteria

1. History of psychosis
2. Asthma
3. Known allergy to cannabis constituents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cannabidiol	Cannabidiol	-
Cannabidiol	Calcineurin inhibitor	-
Cannabidiol	Methylprednisolone	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with complete remission of acute GVHD	90 days

Secondary Outcome Measures

Name	Time	Method
Transplant related mortality	12 months
Proportion of patients with partial remission of acute GVHD	90 days
Proportion of patients able to discontinue immunosuppression	12 months
Proportion of patients with chronic GVHD	12 months

Trial Locations

Locations (1)

Davidof Cancer Center, Beilinson hospital, Rabin medical center; 🇮🇱 Petach Tikva, Israel